Haswanth Yerneni

About Haswanth Yerneni

Experienced Quality Engineer with a strong background in the medical device industry…

Experience

1. Quality Engineer

   Lumin Innovations

   Jul 2022 — Present · US

   Ensuring quality and compliance for manufacturing readiness quality planning, and reviewing and assessing Quality Notifications, Complaints, and cGMP activities across product lines.• Reviewing and approving Quality System documentation, technical reports, validation and quality plans, SOPs, risk analyses, and design control documents in compliance with GMP, FDA, and ISO requirements.• Working on quality system design with a focus on design control, DHF remediation, and risk management processes (ISO 14971).• Identifying and defining CTQ dimensions that require Capability Studies, and analyzing CTQs in Product Specifications to modify Design Inputs.• Reviewing test protocols, input requirements, design specifications, V&V activities, hazard analyses, and traceability per ISO 14971, FDA QSR, and ISO 13485.• Supporting new product development, evaluating product field performance and reliability, recommending corrective actions, and planning for continuous improvement.• Interpreting and applying GD & T to measurement methods, performing Test Method Validation (TMV), and conducting gauge R&R studies for inspection tools.• Ensuring compliance with FDA, ISO 13485, ISO 14971, and international regulatory standards, and supporting EUMDR compliance preparation.• Providing support during design transfer phases of new product development for quality assurance activities.• Managing site validation activities, including equipment qualification and process validations (IQ, OQ, PQ).• Creating master validation plans, sample requests (characterization and validation), inspection requests, and Bills of Materials (BOMs).

Education

• NTTF (Nettur Technical Training Foundation)

  Diploma of Education

• Vignan's Foundation for Science, Technology & Research

  Bachelor of Technology - BTech